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2015 ; 4
(3
): 198-204
Nephropedia Template TP
gab.com Text
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English Wikipedia
Screening and Monitoring for Infectious Complications When Immunosuppressive
Agents Are Studied in the Treatment of Autoimmune Disorders
#MMPMID26336066
Loechelt BJ
; Green M
; Gottlieb PA
; Blumberg E
; Weinberg A
; Quinlan S
; Baden LR
J Pediatric Infect Dis Soc
2015[Sep]; 4
(3
): 198-204
PMID26336066
show ga
Significant progress has been made in the development, investigation, and
clinical application of immunosuppressive agents to treat a variety of autoimmune
disorders. The expansion of clinical applications of these new agents requires
the performance of large multicenter clinical trials. These large clinical trials
are particularly important as one considers these agents for the treatment of
type 1 diabetes, which although autoimmune in its pathogenesis, is not
classically treated as an autoimmune disorder. Although these agents hold promise
for amelioration or cure of this disease, they have the potential to facilitate
infectious complications. There are limited data regarding the prospective
assessment of infectious risks with these agents in trials of this nature.
Pediatric subjects may be at greater risk due to the higher likelihood of primary
infection. A subgroup of experts associated with TrialNet (a National Institutes
of Health [NIH]-funded Type 1 diabetes mellitus research network) with expertise
in infectious diseases, immunology, and diagnostics developed an approach for
screening and monitoring of immunosuppression-associated infections for
prospective use in clinical trials. The goals of these recommendations are to
provide a structured approach to monitor for infections, to identify specific
laboratory testing and surveillance methods, and to consider therapies for
treatment of these potential complications. Prospective evaluations of these
infectious risks allow for greater scientific rigor in the evaluation of risk,
which must be balanced with the potential benefits of these therapies. Our
experience supports an important role for investigators with expertise in
infections in immunocompromised individuals in protocol development of
immunosuppressive trials in type 1diabetes and potentially other autoimmune
diseases.